Biological tissue access and closure apparatus, systems and methods

ABSTRACT

A system for piercing through biological tissue and providing access to internal structures; particularly, intra-abdominal structures, and closing an opening in the tissue. The system includes a suture guide sub-system having a tissue positioning sub-system for engaging segments of tissue disposed proximate the tissue opening and a suture passer sub-system that slideably engages the suture guide sub-system. The suture passer sub-system includes suture deployment and capture means that is configured to removably secure a suture thereto and deliver the suture to the segments of tissue disposed proximate the tissue opening.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a division of U.S. application Ser. No. 15/991,441,filed on May 29, 2018.

FIELD OF THE INVENTION

The present invention relates to apparatus, systems and methods foraccessing internal structures and closing biological tissue. Moreparticularly, the present invention relates to apparatus, systems andmethods for accessing internal structures; particularly, intra-abdominalstructures, and approximation, ligation, fixation and closure ofopenings in biological tissue; particularly, laparoscopic ports orincisions in biological tissue.

BACKGROUND OF THE INVENTION

As reported in a Jan. 31, 2017 iData Research press release,approximately 3.5 million laparoscopic surgical procedures areperfoinied each year in the U.S and more than 7.5 million worldwide. Themost common laparoscopic surgical procedures include a cholecystectomy,appendectomy, gastric bypass, nephrectomy and hernia repair.

As illustrated in FIG. 1, a laparoscopic surgical procedure generallycomprises insertion of a trocar/cannula system 10, such as shown inFIGS. 2-4, through layers of body tissue, such as the tissue 16 of anabdominal wall 12, to a desired position proximate an internal organ ofinterest, such as the gallbladder.

As illustrated in FIGS. 2-4, the conventional trocar/cannula system 10comprises two seminal components: (i) a central obturator 20, whichcomprises a handle 22, shaft 23 and a puncturing tip 24, and a cannulaport 26. The puncturing tip 24 is configured pierce through tissue andprovide an incision for insertion of the cannula port 26. As discussedbelow, the cannula port 26 is configured to receive surgicalinstruments, e.g., endoscopes, and the like, therein, and, hence,facilitate surgical procedures to be performed inside a body cavity,such as an abdomen cavity 14.

After the puncturing tip 24 and, hence, obturator 20 are disposed in adesired position within the body cavity, the obturator 20 is removedfrom the cannula port 26. The cannula port 26 then provides an access orworking portal through the tissue for surgical instruments to perform adesired surgical procedure inside the body cavity, e.g., a gastricbypass.

As is well known in the art, numerous laparoscopy methods currentlyexist for performing laparoscopic surgical procedures. One of the morecommonly used laparoscopy methods is known as closed laparoscopy.Referring back to FIG. 1, closed laparoscopy employs a sharp needle(e.g., Veress™ needle) to pierce through tissue, such as abdominal walltissue 16, and insufflate the body cavity, e.g., abdominal cavity 14,with an inert gas, such as carbon dioxide (CO₂). The process ofinsufflating the body cavity separates the cavity tissue and associatedstructure, e.g., abdominal wall 12, from the underlying organ(s), thus,creating a space or gap 18 for a surgeon to work within. Atrocar/cannula system is then employed to maintain the insufflated spaceor cavity 18 and provide a working portal through which surgicalinstruments can be passed into and out of the insufflated cavity 18 toperform a desired surgical procedure.

As is also well known in the art, one of the most common post-operativecomplication associated with a laparoscopic surgical procedure is theincidence of trocar-site hernias, where a portion of an organ or fattytissue protrudes through the opening in the tissue created by a trocaraccess portal. It is believed that inadequate closure of the trocaraccess portal is the primary cause of trocar-site hernias.

Various methods for closing a trocar access portal have thus beendeveloped and employed. Although the noted methods can, in mostinstances, be employed to successfully close a trocar access portal,there are several significant drawbacks and disadvantages associatedwith the methods. Indeed, as discussed below, most, if not all, currenttrocar access portal closing methods are typically difficult to perform,require considerable time to execute and do not provide for a simple,reproducible and reliable means of closing the trocar access portal.Illustrative are the trocar access portal closing methods disclosed inU.S. Pat. Nos. 919,138, 3,946,740, 4,621,640, 8,109,943, and Pub. No.2016/0228107.

U.S. Pat. Nos. 919,138, 3,946,740 and 4,621,640 disclose similarconventional methods for closing trocar access portals that compriseguiding a suture engaged to a needle through the trasversalis fasciawith needle-nosed forceps or other specialized apparatus. A majordrawback and disadvantage associated with the disclosed methods is thatthe apparatus and methods are primarily dependent on the dexterity ofthe surgeon operating the apparatus and executing the associatedmethods.

A further disadvantage associated with the methods disclosed in U.S.Pat. Nos. 919,138, 3,946,740 and 4,621,640 is that the surgeon operatingthe apparatus associated with the methods must either perform the trocaraccess portal closure “blind”, i.e. without visual access to interiorbody tissues, e.g., intra-abdominal fascia, or with the assistance of anendoscope inserted into the body cavity from an additional accessportal.

A further disadvantage is that an exposed needle must be handled by asurgeon inside of a body cavity with limited visual access, thus, whichincreases the risk of injury to the local structures inside of apatient, e.g., organs.

A further disadvantage associated with the apparatus and methodsdisclosed in U.S. Pat. Nos. 919,138, 3,946,740 and 4,621,640 is that, ifthe surgeon desires to place more than one suture throw through thetissue, the surgeon must reload the needle into a needle driverapparatus. This can be done extracorporeally, i.e. outside the body, ina manner similar to the initial loading of the suture device, or it canbe done intracorporeally, i.e. inside the body. This process is timeconsuming and oftentimes a frustrating exercise in hand-to-eyecoordination. The apparatus and methods are thus configured and, hence,primarily employed for use in open surgical procedures where there isroom for the surgeon to manipulate the instrument(s).

Another drawback associated with the apparatus and associated methodsdisclosed in U.S. Pat. Nos. 919,138, 3,946,740 and 4,621,640 is that theapparatus can, and often times will, fail to effectively close tissuethat is disposed proximate the trocar access portal, which greatlyincreases the patient's risk of trocar-site herniation at the closuresite. The seminal complications associated with trocar-site herniationinclude organ necrosis and closed loop intestinal obstruction, which canbe life-threating.

A further drawback is that patients with relatively thick body tissuesincrease the difficulty, time and risk of trocar access portal closurecomplications, such as a misplaced suture and/or penetration of apatient's organs with the suture needle.

U.S. Pat. No. 8,109,943 and Pub. No. 2016/0228107 disclose furtherapparatus and methods for closing trocar access portals. The disclosedapparatus generally comprises a trocar device that is loaded withoperator actuated injectors. The injectors are configured and positionedto insert suture anchors with sutures attached thereto into the tissueof a patient, such as an abdominal wall.

A major drawback and disadvantage associated with the methods disclosedin U.S. Pat. No. 8,109,943 and Pub. No. 2016/0228107 is that the stitchproduced does not encompass the anterior fascia and peritoneum and,hence, does not fully close the defect in a traditional manner. Theefficacy of closing only the anterior fascia is often questioned bysurgeons.

Further, the surgeon operating the trocar must again either perform thetrocar access portal closure “blind”, i.e. with limited visual access tointerior body tissues, or with the assistance of an endoscope insertedinto the body cavity from an additional access portal.

A further drawback associated with the methods disclosed in U.S. Pat.No. 8,109,943 and Pub. No. 2016/0228107 is that, even if the trocardevice is appropriately positioned in a patient, there is no means toensure that the anchors will completely penetrate the targeted bodytissues and successfully close the trocar access portal.

A further drawback is that at least two (2) exposed suture needles mustbe handled by a surgeon inside of a patient's body cavity with limitedvisual aid, which, as indicated above, greatly increases the risk ofinjury to the local structures, e.g., organs.

Another drawback associated with the apparatus and methods disclosed inU.S. Pat. No. 8,109,943 and Pub. No. 2016/0228107 is that the sutureanchors are formed from polymeric and/or metallic materials, i.e.non-endogenous material structures, which, after the laparoscopicprocedure, remain anchored in the body tissue of the patient. The sutureanchors thus can, and often times will, elicit an adverse inflammatoryresponse in the patient. There is also a substantial risk of dislodgmentof the suture anchors from body tissue, which can also cause seriouspostoperative complications.

A further method for closing a trocar access portal comprises use of atrocar device manufactured and distributed by Medtronic® under thetradename VersaOne™ All-in-One (AIO) trocar and closure device.

The Medtronic® device, which is illustrated in FIGS. 2-4, employs aguide component that is configured to be positioned in the trocarcannula. The guide component includes two (2) diagonally orientedchannels that are configured to guide a suture through two (2)contra-laterally opposed regions of body tissue, e.g., intra-abdominalfascia. The suture is guided through the two (2) contra-laterallyopposed regions of body tissue using a specialized grasper needle thatcan traverse the diagonally oriented channels and a secondary graspertool controlled from an additional trocar access portal that is disposedproximate the trocar device.

Several drawbacks and disadvantages are similarly associated with theMedtronic® device and associated method. A major drawback anddisadvantage is that there is no reliable means associated with theMedtronic® device for a surgeon to assess whether the device is properlypositioned in (or through) the body tissue of a patient. The devicemerely employs fixed circumferential bands on the device housing toindicate and, hence, ensure desired tissue approximation positioning. Itis, however, very difficult, if not impossible to achieve proper trocardevice positioning for every patient via the fixed circumferential bandsdue to varying body tissue thicknesses encountered frompatient-to-patient. As a result of inaccurate positioning of theMedtronic® device, the associated method can cause unintended damage ortrauma to local tissues. The Medtronic® method can also fail tosuccessfully close a trocar access portal, which can lead to the abovenoted complications, e.g., trocar-site herniation.

A further drawback associated with the Medtronic® method is that themethod requires a secondary grasper tool controlled from an additionaltrocar access portal in order to guide a suture through the two (2)contra-laterally opposed regions of body tissue. A surgeon is thusrequired to induce further tissue trauma by deploying a second trocar ina patient's body tissue to generate an additional trocar access portalfor the grasper tool.

A further drawback associated with the Medtronic® method is that it isextremely difficult and cumbersome to manipulate and engage theintra-cavity suture with the grasper tool.

Another drawback associated with the Medtronic® method is that themethod also requires that at least one (1) sharp instrument beintroduced to and manipulated within a body cavity with limited visualaccess to interior body tissues, which as indicated above, substantiallyincreases the risk of injury to the local structures inside of apatient, e.g., organs.

It is thus desirable to provide an improved tissue closure system andmethod that substantially reduces or eliminates the disadvantages anddrawbacks associated with conventional, known tissue closure andassociated methods.

It is therefore an object of the present invention to provide tissueclosure systems and associated methods that substantially reduce oreliminate the disadvantages and drawbacks associated with conventional,known tissue closure apparatus and associated methods.

It is a further object of the present invention to provide tissue accessand closure systems that can be readily employed to facilitate variouslaparoscopic surgical procedures in a simple and economical manner.

It is a further object of the present invention to provide tissue accessand closure systems that can be readily employed to access internalstructures; particularly, intra-abdominal structures in a minimallyinvasive manner.

It is a further object of the present invention to provide tissue accessand closure systems that can be readily employed to effectivelyapproximate, ligate, fixate and close biological tissue; particularly,laparoscopic ports or incisions in biological tissue.

SUMMARY OF THE INVENTION

The present invention is directed to apparatus, systems and methods thatare configured to (i) pierce through tissue and provide access tointernal structures; particularly, intra-abdominal structures, and (ii)close openings in biological tissue, more preferably, approximate and/orligate and/or fixate and close openings in biological tissue;particularly, laparoscopic ports or incisions in biological tissue.

In a preferred embodiment of the invention, the tissue access andclosure (TAC) systems of the invention comprise a cannula sub-system,suture guide sub-system, tissue positioning sub-system and suture passersub-system.

In a preferred embodiment, the cannula sub-system comprises a cannulabase member and a cannula shaft, which is in direct communication with,i.e. secured to, the base member.

The cannula base member further comprises a continuous, preferably,unobstructed cannula lumen that extends through the base member andshaft.

In a preferred embodiment, the cannula lumen is sized and configured toreceive a suture guide sub-system of the invention therein. The cannulalumen also defines an access port for surgical instruments thatfacilitates entry thereof into a body cavity when the cannula sub-systemis positioned therein.

In a preferred embodiment of the invention, the suture guide sub-systemcomprises a guide base, guide shaft and a tissue positioning sub-system.

In a preferred embodiment, the tissue positioning sub-system comprises anotch region disposed on the distal end of the guide shaft that isconfigured to receive target tissue therein.

In a preferred embodiment, the tissue positioning sub-system furthercomprises a suture capture door system that is configured to capture asuture disposed therein.

In a preferred embodiment, the suture guide sub-system comprises acontinuous, preferably, unobstructed cannula lumen that extends throughthe guide base and shaft, which is sized and configured to receive asuture passer sub-system therein.

In a preferred embodiment of the invention, the suture passer sub-systemcomprises a housing (or handle), actuator, compression spring, suturedeployment shaft and tubular cannula shaft, which is configured toreceive the suture deployment shaft therein.

In a preferred embodiment, the suture deployment shaft includes suturedeployment and capture means that is configured to removably secure asuture thereto and deliver the suture to target tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features and advantages will become apparent from the followingand more particular description of the preferred embodiments of theinvention, as illustrated in the accompanying drawings, and in whichlike referenced characters generally refer to the same parts or elementsthroughout the views, and in which:

FIG. 1 is an illustration of a prior art laparoscopic surgical procedureemploying a conventional trocar apparatus;

FIG. 2 is a front plan view of a prior art cannula port;

FIG. 3 is a front plan view of a prior art obturator that is configuredto cooperate with the cannula port shown in FIG. 2;

FIG. 4 is a front plan view of a prior art trocar assembly comprisingthe cannula port and obturator shown in FIGS. 2 and 3;

FIG. 5 is an exploded view of one embodiment of a tissue access andclosure system, illustrating a cannula, suture guide and suture passersub-system thereof, according to the invention;

FIG. 6 is a front plan view of one embodiment of cannula sub-system,according to the invention;

FIG. 7 is a front plan view of one embodiment of a suture guidesub-system with a cooperating suture passer sub-system, according to theinvention;

FIGS. 8A-8C are partial prospective views of the suture guide sub-systemshown in FIG. 7, illustrating one embodiment of a tissue positioningsub-system, according to the invention;

FIG. 9 is a perspective view of another embodiment of suture guidesub-system with a cooperating suture passer sub-system, according to theinvention;

FIG. 10 is a partial prospective view of the suture guide sub-systemshown in FIG. 9, illustrating another embodiment of a tissue positioningsub-system, according to the invention;

FIG. 11 is a partial prospective, sectional view of the suture guidesub-system shown in FIG. 9, illustrating one embodiment of a continuousinternal lumen therein, according to the invention;

FIGS. 12A and 12B are partial prospective views of the suture guidesub-system shown in FIG. 9, illustrating the suture capture clip of thesuture capture door system of the suture guide sub-system that is shownin FIG. 10, according to the invention;

FIG. 13 is a prospective view of one embodiment of a suture capture clipthat is configured to cooperate with the suture capture door systemshown in FIGS. 12A and 12B, according to the invention;

FIG. 14 is a perspective view of one embodiment of a suture passersub-system, according to the invention;

FIG. 15 is a partial front plane view of the suture passer sub-systemshown in FIG. 14, illustrating the housing thereof, according to theinvention;

FIG. 16 is a partial front plan sectional view of the suture passersub-system shown in FIG. 14, according to the invention;

FIG. 17A is a partial perspective view of one embodiment of a suturepasser sub-system cannula shaft, according to the invention;

FIGS. 17B and 17C are partial perspective views of another embodiment ofa suture passer sub-system cannula shaft, according to the invention;

FIG. 18 is a partial perspective view of the cannula shaft shown in FIG.17A, illustrating one embodiment of suture capture means, i.e. a tongmember, extended out of the cannula shaft in an extended state,according to the invention;

FIGS. 19A-19C are perspective views of the cannula shaft shown in FIGS.17A and 18, illustrating a suture connected to the suture capture meansand the suture capture means in several stages of retraction in thecannula shaft, according to the invention;

FIG. 19D is a further perspective view of the cannula shaft shown inFIGS. 17A and 18, illustrating the release of the suture from the suturecapture means when the suture capture means is in a fully retractedstate in the cannula shaft, according to the invention;

FIGS. 20A and 20B are perspective views of the cannula shaft shown inFIGS. 17B and 17C, illustrating the release of a suture from the suturecapture means when the suture capture means is in a fully retractedstate in the cannula shaft, according to the invention;

FIG. 21 is a flow chart, illustrating one embodiment of a method foraccessing biological tissue and closing an opening in the tissue,according to the invention;

FIG. 22 is a front plan view of the assembled cannula and suture guidesub-systems shown in FIGS. 5, 6 and 7, according to the invention;

FIGS. 23A and 23B are front plan views of the assembled cannula, sutureguide and suture passer sub-systems shown in FIGS. 5, 6 and 7,illustrating the engagement of biological tissue with a tissuepositioning sub-system, according to the invention;

FIG. 24 is a front plan view of the assembled cannula and suture guidesub-systems shown in FIGS. 5, 6 and 7 withdrawn from biological tissue,illustrating the placement of a suture by a suture passer sub-system,according to the invention;

FIG. 25 is a perspective view of one embodiment of a tissue closuresystem, according to the invention;

FIG. 26 is an exploded perspective view of the tissue closure systemshown in FIG. 25, according to the invention;

FIG. 27 is a flow chart, illustrating one embodiment of a method forclosing an opening in biological tissue using the tissue closure systemshown in FIG. 25, according to the invention;

FIG. 28 is a partial perspective view of cannula shafts of the tissueclosure system shown in FIG. 25 with ends of a suture operativelyconnected thereto, according to the invention;

FIG. 29A is a partial perspective view of the tissue closure systemshown in FIG. 25 with an actuator in a fully retracted position,according to the invention;

FIG. 29B is another partial perspective view of the tissue closuresystem shown in FIG. 25 with the actuator shown in FIG. 29A in anadvanced position, according to the invention;

FIG. 29C is another partial perspective view of the tissue closuresystem shown in FIG. 25 with the actuator shown in FIG. 29A in apartially retracted position, according to the invention;

FIG. 30A is another partial perspective view of the tissue closuresystem shown in FIG. 25 with the actuator shown in FIG. 29A engaged to asuture snare member, according to the invention;

FIG. 30B is another partial perspective view of the tissue closuresystem shown in FIG. 25, illustrating the position of the cannula shaftin the tissue positioning region, when the actuator shown in FIG. 29A isin an advanced position, according to the invention; and

FIGS. 31A and 31B are front plan views of the tissue closure systemshown in FIG. 25 positioned in a biological tissue structure, accordingto the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Before describing the present invention in detail, it is to beunderstood that this invention is not limited to particularlyexemplified apparatus, systems, structures or methods as such may, ofcourse, vary. Thus, although a number of apparatus, systems and methodssimilar or equivalent to those described herein can be used in thepractice of the present invention, the preferred apparatus, systems,structures and methods are described herein.

It is also to be understood that, although the present invention isdescribed and illustrated in connection with laparoscopic procedures,the invention is not limited to such procedures. According to theinvention, the apparatus, systems and methods of the invention can alsobe employed in connection with a multitude of other surgical procedures,including, without limitation, patent foramen ovale (PFO) closure, leftventricular closure and vascular, i.e. artery and vein, closure.

It is also to be understood that the terminology used herein is for thepurpose of describing particular embodiments of the invention only andis not intended to be limiting.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one having ordinaryskill in the art to which the invention pertains.

Further, all publications, patents and patent applications cited herein,whether supra or infra, are hereby incorporated by reference in theirentirety.

As used in this specification and the appended claims, the singularforms “a, “an” and “the” include plural referents unless the contentclearly dictates otherwise. Thus, for example, reference to “anincision” includes two or more incisions and the like.

Further, ranges can be expressed herein as from “about” or“approximately” one particular value, and/or to “about” or“approximately” another particular value. When such a range isexpressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about” or“approximately”, it will be understood that the particular value formsanother embodiment. It will be further understood that the endpoints ofeach of the ranges are significant both in relation to the otherendpoint, and independently of the other endpoint.

It is also understood that there are a number of values disclosedherein, and that each value is also herein disclosed as “about” or“approximately” that particular value in addition to the value itself.For example, if the value “10” is disclosed, then “approximately 10” isalso disclosed. It is also understood that when a value is disclosedthat “less than or equal to” the value, “greater than or equal to thevalue” and possible ranges between values are also disclosed, asappropriately understood by the skilled artisan. For example, if thevalue “10” is disclosed then “less than or equal to 10” as well as“greater than or equal to 10” is also disclosed.

Definitions

The terms “tissue” and “biological tissue” are used interchangeablyherein, and mean and include mammalian biological tissue, such as, byway of example, human abdominal tissue.

The term “biological cavity”, as used herein, means and includes anycavity or space in a mammalian tissue structure.

The terms “patient” and “subject” are used interchangeably herein, andmean and include warm blooded mammals, humans and primates; avians;domestic household or farm animals, such as cats, dogs, sheep, goats,cattle, horses and pigs; laboratory animals, such as mice, rats andguinea pigs; fish; reptiles; zoo and wild animals; and the like.

The terms “one configuration,” “one embodiment,” “one aspect,” and “aconfiguration,” “an embodiment” and “an aspect,” as used herein, meansthat a particular feature, structure, or characteristic described inconnection with the configuration may be included in at least oneconfiguration and not that any particular configuration is required tohave a particular feature, structure or characteristic described hereinunless set forth in the claim.

The phrase “in one configuration” or similar phrases employed herein donot necessarily refer to the same configuration and, unless specificallystated, do not limit the inclusion of a particular element of theinvention to a single configuration. The element may thus be included inother or all configurations discussed herein.

The term “substantially”, as used herein, means and includes thecomplete or nearly complete extent or degree of an action,characteristic, property, state, structure, item, or result to functionas indicated. For example, an object that is “substantially” enclosedwould mean that the object is either completely enclosed or nearlycompletely enclosed. The exact allowable degree of deviation fromabsolute completeness may in some cases depend on the specific context,such that enclosing nearly all of the length of a lumen would besubstantially enclosed, even if the distal end of the structureenclosing the lumen had a slit or channel formed along a portionthereof.

Use of the term “substantially” is equally applicable when used in anegative connotation to refer to the complete or near complete lack ofan action, characteristic, property, state, structure, item, or result.For example, structure which is “substantially free of” a bottom wouldeither completely lack a bottom or so nearly completely lack a bottomthat the effect would be effectively the same as if it completely lackeda bottom.

The term “comprise” and variations of the term, such as “comprising” and“comprises,” means “including, but not limited to” and is not intendedto exclude, for example, other components, elements or steps.

The following disclosure is provided to further explain in an enablingfashion the best modes of performing one or more embodiments of thepresent invention. The disclosure is further offered to enhance theunderstanding and appreciation for the inventive principles andadvantages thereof, rather than to limit in any manner the invention.The invention is defined solely by the appended claims, including anyamendments made during the pendency of this application, and allequivalents of those claims as issued.

As indicated above, the present disclosure is directed to tissue accessand closure apparatus, systems and methods for accessing internalstructures; particularly, intra-abdominal structures, and closingopenings in biological tissue; particularly, laparoscopic ports orincisions in biological tissue.

In a preferred embodiment of the invention, the tissue access andclosure (“TAC”) systems are configured to (i) pierce through biologicaltissue and provide access to internal structures; particularly,intra-abdominal structures, and (ii) close openings in biologicaltissue, more preferably, approximate and/or ligate and/or fixate andclose openings in biological tissue; particularly, laparoscopic ports orincisions in biological tissue.

As discussed in detail below, in a preferred embodiment of theinvention, the TAC systems of the invention comprise the followingsub-systems: (i) a cannula sub-system, (ii) suture guide sub-system,(iii) tissue positioning sub-system, and (iv) suture passer sub-system.

Referring now to FIG. 5, there is shown an exploded view of oneembodiment of a TAC system (denoted “100”) of the invention comprising acannula sub-system 200, suture guide sub-system 300, tissue positioningsubsystem 400, and suture passer sub-system 500.

Referring now to FIGS. 6-20, each of the noted sub-systems will now bedescribed in detail.

Cannula Sub-System

Referring first to FIG. 6, there is shown one embodiment of a cannulasub-system 200 a of the invention. As illustrated in FIG. 6, the cannulasub-system 200 a comprises a cannula base member 202, comprisingproximal and distal ends 212, 214, and a cannula shaft 204, which alsocomprises proximal and distal ends 216, 218. In a preferred embodiment,the cannula shaft proximal end 216 is in direct communication with, i.e.secured to, the base member distal end 214.

As further illustrated in FIG. 6, the cannula base member 202 includes afirst cannula lumen 208 a, which extends from the proximal end 212 tothe distal end 214 of the base member 202, and the cannula shaft 204includes a second cannula lumen 208 b, which extends from the proximalend 216 to the distal end 218 of the cannula shaft 204.

In a preferred embodiment of the invention, the first and second cannulalumens 208 a, 208 b comprise the same diameter and are in an alignedrelationship (forming a continuous, preferably, unobstructed cannulalumen 208 c) when the cannula base member 202 is engaged to the cannulashaft 204, i.e. the cannula shaft proximal end 216 is in directcommunication with, i.e. secured to, the base member distal end 214.

As discussed in detail below, the first and second cannula lumens 208 a,208 b and, hence, continuous cannula lumen 208 c are sized andconfigured to receive a suture guide sub-system 300 of the inventiontherein. According to the invention, the continuous cannula lumen 208 calso defines an access port for surgical instruments that facilitatesentry thereof into a body cavity when the cannula sub-system 200 ispositioned therein.

In a preferred embodiment of the invention, the diameter of the firstand second cannula lumens 208 a, 208 b and, hence, continuous cannulalumen 208 c is in the range of 8-20 mm.

According to the invention, the cannula shaft distal end 210 cancomprise various configurations, including, but not limited to, abeveled, curved and serrated edge, which is configured to pierce throughbiological tissue.

As illustrated in FIG. 6, in a preferred embodiment, the cannula shaftdistal end 210 comprises a beveled edge having an angle “α” in the rangeof approximately 1°-90° with respect to the longitudinal axis 215 of thecannula shaft 204. More preferably, the angle “α” of the beveled cannulaend 210 is in the range of approximately 45°-90°.

According to the invention, the cannula shaft 204 can also comprisevarious conventional materials, including, but not limited to, metal andpolymeric materials. Thus, in some embodiments, the cannula shaft 204comprises stainless steel. In some embodiments, the cannula shaft 204comprises a shape memory alloy, such as a nickel titanium alloy(Nitinol™).

In some embodiments, the cannula shaft 204 comprises a polymericmaterial. According to the invention, suitable polymeric materialscomprise polyethylene, polyester, polypropylene, acrylic, polycarbonate,and like polymeric materials.

In some embodiments, the cannula shaft 204 comprises textured featureson at least a portion of the cannula shaft exterior surface 220 toreduce the risk of accidental dislodgment of the cannula sub-system 200from a biological tissue structure. According to the invention, suitabletextured features include, but are not limited to, grooves and ribs.

According to the invention, the cannula shaft exterior surface 220 canalso comprise an outer coating that facilitates or eases entry into andthrough body tissue or stabilizes the cannula shaft 204 when positionedin body tissue and/or a body cavity. Suitable coatings comprise, withoutlimitation, polytetrafluoroethylene (PTFE) and parylene coatings.

According to the invention, the cannula shaft 204 can comprise variousdiameters and lengths. In some embodiments, the cannula shaft 204comprises an outer diameter in the range of approximately 5-30 mm. Morepreferably, the outer diameter of the cannula shaft 204 is in the rangeof approximately 10-20 mm.

In some embodiments, the cannula shaft 204 comprises a length in therange of approximately 1-500 min. More preferably, the length of thecannula shaft 204 is in the range of approximately 75-200 mm.

In some embodiments, the cannula shaft wall 222 comprises a thickness inthe range of 1-10 mm. More preferably, the thickness of the cannulashaft wall 222 is in the range of approximately 0.25-4 mm.

In some embodiments of the invention, the cannula sub-system 200 a isfurther configured to insufflate a cavity in a biological tissuestructure, e.g., an intra-abdominal cavity. In the noted embodiments,the cannula subsystem 200 a includes an insufflation sub-system 224(shown in phantom) that is configured to receive an insufflationmanagement system.

In some embodiments, the cannula insufflation sub-system 224 isconfigured to receive and operate in conjunction with a CONMED® AirSeal®iFS insufflation management system.

As illustrated in FIG. 6, in one embodiment of the invention, thecannula sub-system 200 a includes a cannula spacer 230, which, asdiscussed in detail below, is configured to receive and position asuture guide sub-system 300 of the invention in a “tissue accessconfiguration.”

As further illustrated in FIG. 6, the cannular spacer 230 comprises aninternal lumen 232 and proximal and distal ends 234, 236.

According to the invention, the cannula spacer 230 is preferablyconfigured to engage the proximal end 212 of the cannula base member202, wherein the longitudinal axis of the cannula spacer 230 (denoted“240”) and longitudinal axis 215 of the cannula shaft 204 arecoincident. More preferably, the spacer lumen 232 is in an alignedrelationship with the cannula continuous lumen 208 c when the cannulaspacer 230 is engaged to the cannula base member 202.

As discussed in detail below, in a preferred embodiment, the cannulaspacer lumen 232 and continuous cannula lumen 208 c are sized andconfigured to receive a guide sub-system 300 of the invention therein.

In some embodiments, the spacer lumen wall 242 comprises at least onecontinuous groove or notch (not shown) that is in a parallelrelationship with longitudinal axis 215 of the cannula shaft 204. In apreferred embodiment, the groove or notch is configured to receive acooperating protruding element (not shown) disposed on a guidesub-system 300 when the guide sub-system 300 is positioned in thecannula spacer 230 and sub-system 200, whereby rotational movement ofthe suture guide sub-system 300 with respect to the cannula spacer 230and cannula sub-system 200 a is constrained.

Suture Guide Sub-Systems

Referring now to FIG. 7, there is shown one embodiment of a suture guidesub-system 300 a of the invention. As illustrated in FIG. 7, the sutureguide sub-system 300 a comprises a guide base 302, comprising proximaland distal ends 312, 314 and a guide shaft 304, which comprises proximaland distal ends 316, 310, and one embodiment of a tissue positioningsub-system 400 a of the invention.

As further illustrated in FIG. 7, the guide base 302 includes a firstsuture lumen 306 a and a first access lumen 308 a, which extend from theproximal end 312 to the distal end 314 of the guide base 302, and theguide shaft 304 includes a second suture lumen 306 b and a second accesslumen 308 b, which extend from the proximal end 316 of the guide shaft304 to the proximal end 412 of the notch 410.

In a preferred embodiment of the invention, the first and second suturelumens 306 a, 306 b comprise the same diameter and are in an alignedrelationship (forming a continuous suture lumen 306 c) when the guidebase 302 is engaged to the guide shaft 304, i.e. the guide shaftproximal end 316 is in direct communication with, i.e. secured to, thebase distal end 314.

As discussed in detail below, the first and second suture lumens 306 a,306 b and, hence, continuous suture lumen 306 c are sized and configuredto receive a suture passer sub-system 500 of the invention therein.

In some envisioned embodiments of the invention, continuous suture lumen306 c includes at least one continuous suture track or relief (notshown) that is contiguous with the continuous suture lumen 306 c.According to the invention, the suture track facilitates smooth movementof a suture 102 engaged to a suture passer sub-system of the invention,e.g., suture passer sub-system 500 a, discussed below, through thecontinuous suture lumen 306 c, when the suture passer sub-system isinserted in the continuous suture lumen 306 c.

In a preferred embodiment of the invention, the first and second accesslumens 308 a, 308 b also comprise the same diameter and are in analigned relationship (forming a continuous access lumen 308 c) when theguide base 302 is engaged to the guide shaft 304, i.e. the guide shaftproximal end 316 is in direct communication with, i.e. secured to, thebase distal end 314.

As discussed in detail herein, the first and second access lumens 308 a,308 b and, hence, continuous access lumen 308 c are sized and configuredto provide an access port for surgical instruments, e.g., endoscope,that facilitates entry thereof into a body cavity when a guidesub-system 300 of the invention is positioned therein.

As further illustrated in FIG. 7, in some embodiments of the invention,the suture guide sub-system 300 a also comprises a dilating tip 318 thatis disposed on the distal end 310 of the guide shaft 304. According tothe invention, the dilating tip 318 can comprise various configurations,including, but not limited to, conical, arrow-tipped and unibit shapes.

In some embodiments, the dilating tip 318 comprises a bladed tip. In apreferred embodiment, the dilating tip 318 comprises a bladeless tip toreduce trauma or damage to biological tissue when the guide sub-system300 a is deployed therein.

In some embodiments, the dilating tip 318 is removeably secured to thedistal end 310 of the guide shaft 304. In some embodiments, dilating tip318 is permanently secured to the distal end 310 of the guide shaft 304

According to the invention, the dilating tip 318 can also comprisevarious conventional materials, including, but not limited to, any ofthe aforementioned metal and polymeric materials.

In some embodiments, the dilating tip 318 comprises a transparent ortranslucent material that allows an endoscope or other optical device toconduct imaging therethrough.

According to the invention, the guide shaft 304 can similarly comprisevarious diameters and lengths. In a preferred embodiment, the outerdiameter of the guide shaft 304 is slightly less than the diameter ofthe continuous cannula lumen 208 c, whereby the guide shaft 304 can beinserted therein. More preferably, the tolerance or clearance betweenthe guide shaft 304 and continuous cannula lumen 208 c when the guideshaft 304 is disposed therein is in the range of approximately 0.1-0.5mm.

In some embodiments, the guide shaft 304 preferably comprises a lengthin the range of approximately 1-500 mm. In a preferred embodiment, thelength of the guide shaft 304 is in the range of approximately 75-200mm.

In some embodiments of the invention, the guide shaft 304 similarlycomprises textured features on at least a portion of the guide shaftexterior surface 320 to reduce the risk of accidental dislodgment of thesuture guide sub-system 300 a from biological tissue or a tissuestructure.

In some embodiments, at least a portion of the guide shaft exteriorsurface 320 comprises an outer coating that eases entry into and throughbody tissue or stabilizes the guide shaft 304 when positioned in bodytissue and/or a body cavity, i.e. restricts translation of the guideshaft 304 when positioned in body tissue. Suitable coatings similarlycomprise, without limitation, PTFE and parylene coatings.

In some embodiments, the distal end 314 of the suture guide sub-system300 a is configured to releasably engage the proximal end 212 of thecannula sub-system base member 202.

In some embodiments, the suture guide sub-system 300 a further comprisesan operator actuated lock and release mechanism that operates inconjunction with cannula sub-system 200 a to removeably secure thesuture guide sub-system 300 a to the cannula sub-system 200 a. Accordingto the invention, the lock and release mechanism can comprise anyconventional lock and release mechanism applicable to a TAC system 100of the invention, including, without limitation, a disengageable pushlock or plunger lock.

As indicated above, in a preferred embodiment of the invention, thesuture guide sub-systems 300 of the invention further comprise a tissuepositioning sub-system 400, which is a seminal feature of the sutureguide sub-systems 400 and, hence, TAC systems 100 of the invention.

Referring now to FIGS. 8A-8C, one embodiment of the tissue positioningsub-system 400 a of the invention will be described in detail.

As illustrated in FIGS. 8A-8C, in a preferred embodiment of theinvention, the tissue positioning sub-system 400 a comprises a tissuepositioning notch 410 that comprises proximal and distal ends 412, 414.In some embodiments, the notch 410 preferably has a length from theproximal and distal ends 412, 414 thereof in the range of approximately1-15 mm.

As discussed in detail below, during operation of a TAC system 100 thatincludes suture guide sub-system 300 a, the tissue positioning notch 410is configured to engage and retain at least a portion of biologicaltissue between the proximal and distal ends 412, 414 of the notch 410,when the suture guide sub-system 300 a is at least partially withdrawnfrom a biological tissue structure, e.g., an abdominal cavity.

As further illustrated in FIGS. 7 and 8A-8C, disposed proximate theproximal and distal ends 412, 414 of the notch 410 are continuous suturelumen 306 c and suture lumen 306 d, which is in an aligned relationshipwith continuous suture lumen 306 c.

Referring now to FIGS. 8A-8C, in a preferred embodiment, the tissuepositioning sub-system 400 a comprises a capture clip 402 that ispositioned at an internal location of the guide shaft 304 proximate thedistal end 414 of the tissue positioning notch 410.

As illustrated in FIGS. 8A-8C, the capture clip 402 includes an extendedregion 404 that is disposed proximate the tissue positioning notch 410such that the extended region 404 intersects the longitudinal axis ofsuture lumen 306 d, where the extended region 404 forms a suture capturedoor (or system) 403. According to the invention, the capture door 403is positioned and configured to capture a suture transferred into suturelumen 306 d of the guide shaft 304 by a tissue passer sub-system 500during operation of a TAC system 100 of the invention, i.e. when asuture passer sub-system 500 of the invention guides a suture 102 intoand through continuous suture lumen 306 c, notch 410 and suture lumen306 d, the extended region 404 of the capture clip 402 (i.e. suturecapture door 403) transitions, i.e. is deflected or flexed, to an openposition by the suture passer sub-system 500 as the distal end of thesuture passer sub-system 500 (with a suture 102 engaged thereto)traverses beyond the distal end 414 of the tissue positioning notch 410.When the suture passer sub-system 500 is withdrawn from suture lumen 306d, the extended region 404 of the capture clip 402 (i.e. suture capturedoor 403) transitions back to a closed position and captures the suture102.

In a preferred embodiment of the invention, the capture clip 402 furthercomprises an open region 408 which, when the capture clip 402 ispositioned in the guide shaft 304, is in an aligned relationship withaccess lumen 308 d (which is in an aligned relationship with continuousaccess lumen 308 c) allows surgical instruments, such as an endoscope,to enter into and through access lumen 308 d and guide shaft 304.

According to the invention, the capture clip 402 can further comprisestructural features, such as formed ribs, which are designed to enhancethe structural integrity of the thin section created by the notch 410.

In a preferred embodiment of the invention, the force (F) required totransition the extended region 404 of the capture clip 402 from a closedposition to an open position is in the range of approximately 0.1-5.0lbs_(f).

According to the invention, the capture clip member 402 can comprisevarious materials, including, without limitation, metal and polymericmaterials. Thus, in some embodiments, the capture clip member 402comprises stainless steel. In some embodiments, the capture clip 402comprises a shape memory alloy, such as a nickel titanium alloy (e.g.,Nitinol™).

In some embodiments, the capture clip 402 comprises a polymericmaterial, such as one of the aforementioned polymeric materials.

In some embodiments, not shown, the capture door system 403 comprises amanually operated gating mechanism. In such embodiments, the sutureguide sub-system 300 a comprises a slide mechanism that is configured totransition the extended region 404 of the capture clip 402 from a closedposition to an open position.

Referring now to FIGS. 9 and 10, there is shown another embodiment of asuture guide sub-system 300 b of the invention. As illustrated in FIG.9, the guide sub-system 300 b similarly comprises a guide base 323,comprising proximal and distal ends 328, 330, and a guide shaft 322,which comprises proximal and distal ends 324, 326, and a tissuepositioning sub-system 400 b.

As further illustrated in FIGS. 9 and 10, the guide base 323 includes afirst suture lumen 332 a, which extends from the proximal end 328 to thedistal end 330 of the guide base 323, and the guide shaft 322 includes asecond suture lumen 332 b, which extends from the proximal end 324 ofthe guide shaft 322 to the proximal end 412 of the notch 410.

In a preferred embodiment of the invention, the first and second suturelumens 332 a, 332 b similarly comprise approximately the same diameterand are in an aligned relationship (forming a continuous suture lumen332 c) when the guide base 323 is engaged to the guide shaft 322, i.e.the guide shaft proximal end 324 is in direct communication with, i.e.secured to, the base distal end 330.

As discussed in detail below, the first and second suture lumens 332 a,332 b and, hence, continuous suture lumen 332 c are also sized andconfigured to receive a suture passer sub-system 500 of the inventiontherein.

In a preferred embodiment of the invention, continuous suture lumen 332c includes at least one continuous suture track or relief that iscontiguous with (and, hence, in a parallel relationship with) thecontinuous suture lumen 332 c. According to the invention, the suturetrack similarly facilitates smooth movement of a suture 102 engaged to asuture passer sub-system 500 of the invention through the continuoussuture lumen 332 c, when the suture passer sub-system 500 is inserted inthe continuous suture lumen 332 c.

In some embodiments, the continuous suture lumen 332 c comprises asingle suture track or relief.

As illustrated in FIG. 11, in a preferred embodiment of the invention,continuous suture lumen 332 c comprises three (3) suture tracks orreliefs 336 a, 336 b, 336 c.

According to the invention, the distal end 326 of the guide shaft 322can similarly comprise various configurations, including, but notlimited to, conical, pyramid and unibit shapes.

In some embodiments, the distal end 326 comprises a bladed tip. In apreferred embodiment, the distal end 326 comprises a bladeless tip toreduce trauma or damage to biological tissue when the suture guidesub-system 300 b is deployed therein.

According to the invention, the guide shaft 322 can similarly comprisevarious diameters and lengths. In some embodiments, the diameter of theguide shaft 322 is similarly slightly less than the diameter of thecontinuous cannula lumen 208 c, whereby the guide shaft 322 can beinserted therein. More preferably, the tolerance or clearance betweenthe guide shaft 322 and continuous cannula lumen 208 c when the guideshaft 322 in disposed therein is similarly in the range of approximately0.1-1.0 mm.

According to the invention, the suture guide sub-system 300 b can alsocomprise a stand-alone suture guide system, i.e. the guide sub-system300 b can be employed to directly access and close tissue without theuse of a cannula sub-system 200.

In some embodiments, the guide shaft 322 similarly preferably comprisesa length in the range of approximately 1-500 mm. In a preferredembodiment, the length of the guide shaft 322 is in the range ofapproximately 100-200 mm.

In some embodiments of the invention, the guide shaft 322 similarlycomprises textured features on at least a portion of the guide shaftexterior surface 334 to reduce the risk of accidental dislodgment of thesuture guide sub-system 300 b from biological tissue or tissuestructure.

In some embodiments, at least a portion of the guide shaft exteriorsurface 334 comprises an outer coating that eases entry into and throughbody tissue or stabilizes the guide shaft 322 when positioned in bodytissue and/or a body cavity, i.e. restricts translation of the guideshaft 322 when positioned in body tissue. Suitable coatings similarlycomprise, without limitation, PTFE and parylene coatings.

In some embodiments, the suture guide sub-system 300 b further comprisesan operator actuated lock and release mechanism that operates inconjunction with cannula sub-system 200 to removeably secure the sutureguide sub-system 300 b to the cannula sub-system 200. According to theinvention, the lock and release mechanism can similarly comprise anyconventional lock and release mechanism applicable to a TAC system 100of the invention, including, without limitation, a disengageable pushlock or plunger lock.

As indicated above, in a preferred embodiment of the invention, thesuture guide sub-system 300 b also comprises a tissue positioningsub-system 400 b.

Referring now to FIGS. 12A, 12B and 13, the tissue positioning subsystem400 b will be described in detail.

As illustrated in FIGS. 12A, 12B and 13, in a preferred embodiment ofthe invention, the tissue positioning subsystem 400 b similarlycomprises tissue positioning notch 410, which, as indicated above, isconfigured to engage and retain at least a portion of biological tissuebetween the proximal and distal ends 412, 414 of the notch 410 when theguide sub-system 300 b is at least partially withdrawn from a biologicaltissue structure, e.g., an abdominal cavity.

As further illustrated in FIGS. 9, 10, 12A and 12B, disposed proximatethe proximal and distal ends 412, 414 of the notch 410 are continuoussuture lumen 332 c and suture lumen 332 d, which is in an alignedrelationship with continuous suture lumen 332 c.

As illustrated in FIG. 11, in a preferred embodiment, suture lumen 332 dalso comprises continuous grooves or notches 336 a, 336 b, 336 c. Insome embodiments, suture lumen 332 d comprises a plurality of continuousgrooves or notches. In some embodiments, the suture lumen 332 dcomprises a single continuous groove or notch.

Referring now to FIGS. 12A, 12B and 13, in a preferred embodiment, thetissue positioning subsystem 400 b also comprises a capture clip 416that is positioned at an internal location of the guide shaft 322proximate the distal end 414 of the tissue positioning notch 410.

As illustrated in FIGS. 12A, 12B and 13, the capture clip 416 similarlyincludes an extended region 420 that is disposed proximate the suturelumen 332 d, where the extended region 420 similarly forms a suturecapture door (or system) 418.

In a preferred embodiment, the suture capture door 418 similarlyfacilitates the capture of a suture transferred into suture lumen 332 dof the guide shaft 322 by a tissue passer sub-system 500 in a mannerthat is similar to suture capture door 403 discussed above, i.e. when asuture passer sub-system 500 of the invention guides a suture 102 intoand through continuous suture lumen 332 c, notch 410 and suture lumen332 d, the extended region 420 of the capture clip 416 transitions, i.e.is deflected or flexed, to an open position by the suture passersub-system 500 as the distal end of the suture passer sub-system 500(with a suture 102 engaged thereto) traverses beyond the distal end 414of the tissue positioning notch 410. When the suture passer sub-system500 is withdrawn from suture lumen 332 d, the extended region 420 of thecapture clip 416 (i.e. suture capture door 418) transitions back to aclosed position and captures the suture 102.

According to the invention, the capture clip 416 can similarly comprisestructural features, such as formed ribs, that are designed to enhancethe structural integrity of the notch 410 region.

In a preferred embodiment of the invention, the force (F) required totransition the extended region 420 of the capture clip 416 from a closedposition to an open position is similarly in the range of approximately0.1-5.0 lbs_(f).

According to the invention, the capture clip member 416 can alsocomprise various materials, including, without limitation, metal andpolymeric materials. Thus, in some embodiments, the capture clip 416comprises stainless steel. In some embodiments, the capture clip 416comprises a shape memory alloy, such as a nickel titanium alloy (e.g.,Nitinol™).

In some embodiments, the capture clip 416 comprises a polymericmaterial, such as one of the aforementioned polymeric materials.

According to the invention, the suture capture door system 418 cansimilarly comprise a manually operated gating mechanism. In suchembodiments, the suture guide sub-system 300 b includes a slidemechanism that is configured to transition the extended region 420 ofthe capture clip 416 from a closed position to an open position.

Suture Passer Sub-System

Referring now to FIGS. 14-16, 17A-17C, 18 and 19A-19D, there is shownone embodiment of a suture passer sub-system 500 a of the invention. Asillustrated in FIGS. 7 and 9, and discussed in detail herein, in apreferred embodiment, the suture passer sub-system 500 a is adapted tocooperate with a suture guide sub-system 300 of the invention, such assuture guide sub-systems 300 a and 300 b.

As illustrated in FIGS. 14-16, in a preferred embodiment, the suturepasser sub-system 500 a comprises a housing (or handle) 510, actuator530, compression spring 534, suture deployment shaft (i.e. needle) 540and tubular cannula shaft 560, which is configured to receive the suturedeployment shaft 540 therein.

As discussed in detail below and illustrated in FIG. 18, the suturedeployment shaft 540 includes suture deployment and capture means 550that is disposed on the distal end of the suture deployment shaft 540.In a preferred embodiment, the suture deployment and capture means 550is configured to capture and removably secure a suture 102 therewith.

In some embodiments, the housing 510 comprises proximal and distal ends,512, 514 at least one, more preferably, two (2) finger contours 516 a,516 b to facilitate a controlled grip and manipulation of the suturepasser sub-system 500 a.

As illustrated in FIGS. 14 and 15, the actuator 530 and suturedeployment shaft 540 are preferably joined (or coupled) via anactuator-deployment shaft pin 532, whereby, when a sufficient actuationforce is exerted on the actuator 530, the suture deployment shaft 540transitions from a retracted position (or state) to an extendedposition.

As also illustrated in FIGS. 14 and 15, the housing 510 furthercomprises a guide slot 518, which is preferably disposed adjacent fingercontours 516 a, 516 b. According to the invention, the guide slot 518 ispositioned and configured to receive the actuator-deployment shaft pin532 and control travel of the actuator 530 and, hence, suture deploymentshaft 540.

Referring now to FIG. 16, the interior of the housing 510 (denotedgenerally “520”) is configured to receive, contain and providestructural support for the actuator 530, suture deployment shaft 540 andthe compression spring 534. The distal end 514 of the housing 510 isfurther configured to receive and secure the cannula shaft 560 to thehousing 510.

According to the invention, the compression spring 534 is positioned andconfigured to exert a spring force (denoted by arrow F_(s)) on theactuator 530 and, thereby, suture capture shaft 540, when the actuator530 is in a static (i.e. retracted) state.

Preferably, the actuator 530 is able to axially advance the suturedeployment shaft 540 inside of the cannula shaft 560 from a retractedposition to an extended position with minimal force exerted on theactuator 530 with an operator's thumb. Thus, in a preferred embodiment,the spring force (F_(s)) exerted on the actuator 530 by the compressionspring 534 when the actuator 530 is in a static state is in the range ofapproximately 0.5-4.0 lbs_(f).

As indicated above, in a preferred embodiment, the housing guide slot518 is configured and sized to limit axial advancement of theactuator-deployment shaft pin 532 and, hence, suture deployment shaft540, when an actuation force is exerted on the actuator 530 by anoperator. Thus, full thumb force can be exerted on the actuator 530 byan operator without concern that the suture deployment shaft 540 willover extend.

Referring now to FIG. 17A, in a preferred embodiment of the invention,the cannula shaft 560 preferably includes a beveled edge 564 on thedistal end 562 thereof, which is configured to pierce through tissue tofacilitate suture passage. In a preferred embodiment of the invention,the angle “γ” of the beveled edge 564 with respect to the longitudinalaxis of the cannula shaft 560 (denoted “CLA”) is in the range of10°-40°.

According to the invention, the edge 564 of cannula shaft 560 cancomprise various alternative shapes to facilitate piercing thoughtissue.

Referring now to FIGS. 17B and 17C, in some embodiments of theinvention, the cannula shaft (now denoted “561”) further comprises apair of dimples 567 a, 567 b that are preferably disposed on opposingsides of the cannula shaft 561. According to the invention, the dimples567 a, 567 b are sized and positioned on the cannula shaft 561 tofacilitate the release of a captured suture 102 by the suture deploymentand capture means 550 of the suture passer sub-system 500 a, asdiscussed below.

As indicated above, the suture deployment shaft 540 includes suturedeployment and capture means 550 that is configured to capture andremovably secure a suture 102 therewith. As illustrated in FIG. 18, in apreferred embodiment, the suture deployment and capture means 550comprises a tong member 551 having an elongated top portion 552 and acooperating elongated bottom portion 554.

In a preferred embodiment of the invention, the elongated top and bottomportions 552, 554 of the tong member 551 are configured or pre-shaped totransition from a restrained static or pre-deployment configuration whenthe suture deployment shaft 540 is in a retracted position, wherein, asillustrated in FIG. 19C, the tong member 551 is disposed in the cannulalumen 563, to an expanded (or unrestrained) configuration, when thesuture deployment shaft 540 is in an extended position and the tongmember 551 is extending out of the cannula lumen 563, as illustrated inFIG. 18.

As further illustrated in FIG. 18, when the tong member 551 is in theextended position, the elongated top portion 552 is disposed at an angleθ with respect to the elongated bottom portion 554, whereby an openregion (denoted “OR”) is provided between the elongated top and bottomportions 552, 554 of the tong member 551.

As also illustrated in FIG. 18, in a preferred embodiment, the elongatedtop portion 552 of the tong member 551 comprises a first substantiallylinear segment 556 a, a second substantially linear segment 556 b, whichis disposed at an angle with respect to first segment 556 a, and alinear distal end 556 c, which is disposed at an angle) with respect tothe linear segment 556 b.

In a preferred embodiment, angle β is in the range of 5°-15° to, asdiscussed below, provide a supplemental suture engagement force upon anengaged suture 102 when the tong member 551 is being retracted into thecannula lumen 563.

In a preferred embodiment, angle λ is in the range of 2°-30° to, as alsodiscussed below, facilitate release of a suture 102 when the tong member551 is in a restrained state, i.e. a static or pre-deploymentconfiguration, in the cannula lumen 563.

Referring now to FIGS. 19A-19D, engagement of a suture 102 with the tongmember 551 and release of the suture 102 therefrom will now be describedin detail.

According to the invention, to facilitate initial suture capture, thesuture deployment shaft 540 is axially advanced from a static/retractedposition in the cannula lumen 563 to an extended position shown in FIG.18 by exerting an actuation force on the actuator 530 in the directiondenoted by arrow F_(A), wherein the tong member 551 is exposed. Asillustrated in FIG. 18, a suture 102 can then be positioned in the openregion “OR” (i.e. seated in the open region) of the tong member 551.

After the suture 102 is seated in the open region “OR” of the tongmember 551, the actuator 530 is released and the spring force F_(s)exerted by the spring 534 on the actuator 530 withdraws (or retracts)the suture deployment shaft 540 and, hence, tong member 551 with thesuture 102 connected thereto into the cannula shaft 560, as shown inFIGS. 19A and 19B.

As illustrated in FIG. 19A, during an initial retraction stage of thetong member 551, the elongated top and bottom portions 552, 554 of thetong member 551 collapse and capture the suture 102, and, preferably,pull the suture 102 against the beveled distal end 562 of the cannula560.

As illustrated in FIG. 19B, further retraction of the tong member 551enables the elongated bottom portion 554 of the tong member 551 torelease the suture 102, while the elongated top portion 552, due to itsgreater bending moment, exerts a greater force on the suture 102 to pullthe suture 102 against the beveled distal end 562 of the cannula 560.

As illustrated in FIG. 19C, further retraction of the tong member 551enables the elongated top portion 552 of the tong member 551 to collapseand secure the suture 102 in and against the cannula shaft lumen 563. Ina preferred embodiment of the invention, the lateral gap between theelongated portion 552 of the tong member 551 and the inside diameter ofthe cannula 560 ranges from 0.1 mm to 1.0 mm per side. A sufficientlateral gap enables the collapse of the suture 102, thus preventingpremature release of the suture 102.

According to the invention, the retention force exerted on a suture 102by the elongated top portion 552 of the tong member 551 when the tongmember 551 is withdrawn into the cannula shaft 560 and, hence, is in astatic/retracted position, wherein, as shown in FIG. 19C, the suture 102is disposed between the elongated top portion 552 and the surface of thecannula shaft lumen 563, is preferably in the range of 0.01-5.0 lbs_(f)to, as shown in FIG. 19D and discussed in detail below, allow the suture102 to be readily released from the tong member 551 when captured by asuture capture door (i.e. 403 or 418) of a suture guide sub-system 300of the invention.

In some embodiments of the invention, the maximum retention forceexerted against a suture 102 by the elongated top portion 552 of thetong member 551 when the tong member 551 is withdrawn into the cannulashaft 560 is less than the closure force (F) of the suture capture door(403 and 418) of the suture guide sub-system 300.

According to the invention, by virtue of the design of the suturecapture doors 403, 418, suture 102 can also be released from the tongmember 551 and captured by a suture capture door 403 or 418 when theretention force exerted on a suture 102 by the elongated top portion 552of the tong member 551 when the tong member 551 is withdrawn into thecannula shaft 560 is greater than the closure force (F) of the suturecapture door (403 and 418) of the suture guide sub-system 300.

In a preferred embodiment of the invention, the beveled edge 564 of thecannula shaft 560 acts as a strain relief when force is pulled on thesuture 102 in a proximal direction, such as when the suture captureshaft 540 with suture 102 engaged thereto is advanced through tissue.However, due to the shallow angle at the distal end of the elongated topportion 552 of the tong member 551, the force required to release thesuture 102 is low, whereby the suture 102 can be readily released andcaptured by a suture capture door system 403 or 418) of a suture guidesub-system 300 of the invention.

In the embodiments of the cannula shaft 561 shown in FIGS. 17B and 17C,where the cannula shaft 561 includes dimples 567 a, 567 b, therestricted path section or region in the cannula lumen provided by thedimples 567 a, 567 b, would allow the elongated top and bottom portions552, 554 of the tong member 551 to freely traverse through therestricted path region, but would aid in the release of the suture 102when disposed proximate the restricted region, as shown in FIGS. 20A and20B.

According to the invention, the suture deployment shaft 540 and tubularcannula shaft 560 can comprise various conventional materials, such aspolymeric materials and metal alloys. In a preferred embodiment, thesuture deployment shaft 540 and tubular cannula shaft 560 comprisestainless steel.

The housing 510 and actuator 530 of the suture passer sub-system 500 acan similarly comprise various conventional materials. In a preferredembodiment, the housing 510 and actuator 530 comprise a polymericmaterial. According to the invention, suitable polymeric materialsinclude, without limitation, any of the aforementioned polymericmaterials.

TAC System Operation

Operation of a TAC system 100 of the invention will now be described indetail.

As set forth in detail herein, the TAC systems 100 are configured to (i)pierce through biological tissue and provide access to internalstructures; particularly, intra-abdominal structures, to facilitateentry through the tissue with surgical instruments and interaction ofthe surgical instruments with internal structures, and (ii) close anopenings in the biological tissue, more preferably, approximate and/orligate and/or fixate and close openings in biological tissue;particularly, laparoscopic ports or incisions in biological tissue. TheTAC systems 100 of the invention thus preferably comprise two modes: (i)a “tissue access” mode and (ii) a “tissue closure” mode.

Referring now to FIG. 21, there is shown a flow chart illustrating apreferred method 600 of the invention for (i) piercing throughbiological tissue and providing access to internal structures using a“tissue access” assembly of a TAC system 100 of the invention and (ii)closing an opening in the tissue using a “tissue closure” assembly ofthe TAC system 100.

In the preferred method described herein, the “tissue access” assemblycomprises cannula sub-system 200 and spacer 230, shown in FIGS. 5 and 6,and suture guide sub-system 300 a, shown in FIG. 7, and the “tissueclosure” assembly comprises cannula sub-system 200, suture guidesub-system 300 a, and suture passer sub-system 500 a, shown in FIG. 14.

For purposes of describing the preferred method, the tissue structurepierced and closed with the TAC system 100 comprises an abdominal tissuewall 12, comprising an adipose tissue layer 54, a muscle/fascia layer 56and a peritoneum layer 58. The abdominal wall tissue (denotedcollectively “16” herein) also comprises a top skin layer (not shown).

As stated above, the TAC systems 100 of the invention and, hence,methods employing same are not, however, limited to solely piercing andclosing abdominal tissue and structures and/or surgical proceduresrelating thereto. Indeed, the TAC systems 100 of the invention andmethods employing same can also be readily employed to pierce into andthrough other tissue structures (and provide access to internalstructures) and close openings in other tissues and tissue structures.

As illustrated in FIG. 21, after an incision is made in the biologicaltissue (and, hence, tissue structure), the TAC system 100 identifiedabove is configured in a “tissue access configuration” and inserted into(and, preferably, through) the tissue structure, i.e. the openingprovided by the incision [601].

As illustrated in FIGS. 22, 23A and 23B, after the “tissue access”assembly of the TAC system 100 is inserted into the tissue structure,the TAC system 100 is re-configured into a partial “tissue closure”assembly [602], i.e. spacer 230 is removed, wherein tissue positioningsub-system 400 a is exposed.

The partial “tissue closure” assembly, i.e. assembled cannula and sutureguide sub-systems 200, 300 a, is then positioned in an opening 11 (seeFIG. 24) of a biological tissue structure such that the exposed tissuepositioning sub-system 400 a is disposed proximate to and engages afirst portion of biological tissue 60 a [603]. In the illustratedembodiment, the first portion of biological tissue 60 a comprises aportion of intra-abdominal tissue, more preferably, a portion ofmuscle/fascia and peritoneum layers 56, 58.

Referring back to FIG. 21, after the first portion of biological tissue60 a is engaged by the tissue positioning sub-system 400 a [603], thesuture passer sub-system 500 a is inserted into the suture guidesub-system 300 a, i.e. the tubular cannula shaft 560 of the suturepasser sub-system 500 a is inserted into the continuous suture lumen 306c of the suture guide sub-system 300 a [604], whereby the complete“tissue closure” assembly of the TAC system 100 referenced above isformed.

A first portion of suture 102 is then connected to the suture deploymentshaft (or needle) 540 of the suture passer sub-system 500 a and thecannula shaft 560 with the suture deployment shaft 540 (with the firstportion of suture 102 engaged thereto) disposed therein is inserted intoand through the first portion of biological tissue 60 a and suturecapture door 403 of the tissue positioning sub-system 400 a [605].

After the first portion of suture 102 is inserted into and through thefirst portion of biological tissue 60 a and suture capture door 403 ofthe tissue positioning sub-system 400 a with the suture passersub-system 500 a [605], the cannula shaft 560 (and, hence, suturedeployment shaft 540) is withdrawn through of the suture capture door403 and out of the first portion of biological tissue 60 a [606],whereby the first portion of suture 102 is routed through the firstportion of biological tissue 60 a and captured or ensnared by the suturecapture door 403 of the tissue positioning sub-system 400 a.

As illustrated in FIGS. 23A and 23B, after the cannula shaft 560 of thesuture passer sub-system 500 a is withdrawn out of the first portion ofbiological tissue 60 a [606], the suture passer sub-system 500 a isfurther withdrawn in continuous suture lumen 306 c and, preferably, outof the tissue guide sub-system 300 a, and the “tissue closure” assemblyof the TAC system 100 is rotated, preferably, rotated approximately 180°[607], whereby a contralateral second portion of biological tissue 60 bis engaged by the tissue positioning sub-system 400 a of the sutureguide sub-system 300 a.

Referring to FIG. 23B, after the “tissue closure” assembly of the TACsystem 100 is rotated [607], a second portion of suture 102 is connectedto the suture deployment shaft 540 of the suture passer sub-system 500 aand the cannula shaft 560 with the suture deployment shaft 540 (with thesecond portion of suture 102 engaged thereto) disposed therein isinserted into and through a second portion of biological tissue 60 b andpast the suture capture door 403 [608].

After the second portion of suture 102 is inserted into and through thesecond portion of biological tissue 60 b and suture capture door 403with the suture passer sub-system 500 a [608], the cannula shaft 560 issimilarly withdrawn through suture capture door 403 and out of thesecond portion of biological tissue 60 b, whereby the second portion ofsuture 102 is routed through the second portion of biological tissue 60b and ensnared by the suture capture door 403 of the tissue positioningsub-system 400 a [609]. Both the first and second sections of suture 102are now ensnared by the suture capture door 403 of the tissuepositioning sub-system 400 a.

Referring now to FIG. 24, after the suture passer sub-system 500 a iswithdrawn out of the second portion of biological tissue 60 b [609], theassembled cannula and suture guide sub-systems 200, 300 a (i.e. partial“suture closure” assembly) are also withdrawn from the biological tissuestructure, e.g., abdominal wall 12, with the first and second portionsof suture 102 ensnared by the suture capture door system 403 of thetissue positioning sub-system 400 a [610].

After the complete “tissue closure” assembly of the TAC system 100 iswithdrawn from the biological tissue structure [610], the first andsecond portions of the suture 102 are released from the suture door 403and drawn together or tied, e.g., a stitch loop is formed, whereby thefirst and second portions of biological tissue 60 a, 60 b are drawntogether and the opening 11 in the tissue structure is closed, morepreferably, ligated, fixated and closed [611].

According to the invention, a further tissue passer sub-system 500 thatcan also be employed with a TAC system 100 of the invention, i.e. a“tissue closure” assembly thereof, is disclosed in Applicant's U.S. Pat.No. 9,301,748, which is also expressly incorporated herein in itsentirety.

According to the invention, the method 600 illustrated in FIG. 21 anddescribed above can also be performed using suture guide sub-system 300b. The opening in the tissue structure can also be closed using sutureguide sub-system 300 b as a stand-alone tissue closure system.

As discussed in detail below, the opening in the tissue structure canalso be closed using a further tissue closure system of the invention.

Alternative Tissue Closure Systems

Referring now to FIGS. 25 and 26, there is shown an alternative sutureguide system 300 c that can be employed with a TAC system 100 of theinvention, i.e. a “tissue closure” assembly of a TAC system 100, or as astand-alone suture guide and tissue closure system.

As illustrated in FIGS. 25 and 26, in a preferred embodiment of theinvention, the suture guide system 300 c comprises a housing 350, havingan elongated guide region 355 with proximal and distal ends 352, 354 anda handle 356, a pair of sliders 360 a, 360 b, a pair of suture snares372 a, 372 b and a suture 102. According to the invention, the distalend 354 of the housing elongated guide region (beyond the tissuepositioning region 400 c, discussed below) functions as a safety shieldto ensure that the suture cannula shafts 368 a, 368 b, discussed below,do not over extend and puncture undesired tissue.

As illustrated in FIG. 26, each slider 360 a, 360 b includes an actuator367 a, 367 b and a suture cannula shaft 368 a, 368 b, which isoperatively connected thereto. In a preferred embodiment, the actuators367 a, 367 b comprise a raised top region 361 a, 361 b, which isconfigured to facilitate operation of the actuators 367 a, 367 b by anoperator's thumb (or other finger), and a curved bottom region 363 a,363 b comprising a shape that cooperates with the outer shape of thesystem housing 350 (see also FIG. 25)

As further illustrated in FIG. 26, each suture snare 370 a, 370 bincludes an elongated shaft 371 a, 371 b, having a flexible hooked end374 a, 374 b on one end and a flexible suture capture member 372 a, 372b on the opposing end.

As further illustrated in FIG. 26, the housing 350 comprises first andsecond housing sections 350 a, 350 b, i.e. a two-piece structure, which,when operatively connected, form an internal region 365 that isconfigured to receive and guide suture snares 370 a, 370 b and aninternal lumen 366 that is configured to receive and guide the suturecannula shafts 368 a, 368 b. In a preferred embodiment, each housingsection 350 a, 350 b comprises a guide slot 351 a, 351 b that isconfigured to receive a respective one of the flexible looped ends 374a, 374 b of a suture snare 370 a, 370 b.

Referring back to FIG. 25, the housing 350 two-piece structure, whenoperatively connected, further forms a tissue positioning (orengagement) region, i.e. notch, 400 c, which, as discussed in detailbelow, is similarly configured to close biological tissue, morepreferably, approximate and/or ligate and/or fixate and close biologicaltissue; particularly, laparoscopic ports or incisions in biologicaltissue.

Operation of the suture guide system 300 c will now be described indetail.

Although operation of the suture guide system 300 c is described hereinin connection with closing laparoscopic ports, the suture guide system300 c is not limited to merely closing laparoscopic ports. According tothe invention, the suture guide system 300 c can also be employed withor implemented in other surgical apparatus, such as a catheter or otherflexible housing where flexible components of which can be used tofacilitate accessing remote anatomy.

Referring now to FIG. 27, there is shown a flow chart illustratinganother method 650 for closing an opening in biological tissue using thesuture guide system 300 c shown in FIG. 25.

As set forth in the flow chart, i.e. FIG. 27, and illustrated in FIG.28, first and second ends 102 a, 102 b of suture 102 are first loadedinto the distal ends of 369 a, 369 b of cannula shafts 368 a, 368 b,respectively [651].

Referring now to FIG. 29A, after the first and second ends 102 a, 102 bof suture 102 are loaded into the distal ends of 369 a, 369 b of cannulashafts 368 a, 368 b, respectively [651], the first and second actuators367 a, 367 b, i.e. sliders 360 a, 360 b, are positioned in initialretracted positions [652], whereby the first and second distal endsdistal ends of 369 a, 369 b of cannula shafts 368 a, 368 b arepositioned proximate the tissue positioning sub-system 400 c.

As illustrated in FIG. 29A, when the first and second actuators 367 a,367 b are in an initial retracted position, the first and secondflexible hooked ends 374 a, 374 b of the first and second suture snares370 a, 370 b are deflected under the first and second actuators 367 a,367 b, respectively.

Referring again to FIG. 31A, after the first and second actuators 367 a,367 b are positioned in an initial retracted position [652] and anincision is made in the biological tissue (and, hence, structure), theelongated guide region 355 of suture guide system 300 c is inserted into(and, preferably, through) the opening in the tissue structure providedby the incision [653]. In the method embodiment described herein, thebiological tissue structure similarly comprises an abdominal tissue wall12.

After the elongated guide region 355 of suture guide system 300 c isinserted into the tissue structure [653], the elongated guide region 355is positioned in the biological tissue structure such that the exposedtissue positioning region 400 c is disposed proximate to and engages afirst portion of biological tissue 60 a [654]. In this instance, thefirst portion of biological tissue 60 a similarly comprises a portion ofintra-abdominal tissue, more preferably, a portion of muscle/fascia andperitoneum layers 56, 58.

Referring now to FIG. 29B, after the first portion of biological tissue60 a is engaged by the tissue positioning region 400 c [654], the firstactuator 367 a is advanced along the first guide slot 351 a toward thedistal end 354 of the elongated guide region 355 of suture guide system300 c [655]. According to the invention, when the first actuator 367 ais advanced toward the distal end 354 of the suture guide system 300 c,the first cannula shaft 368 a is inserted into and through the firstportion of biological tissue 60 a engaged to the tissue positioningregion 400 c. The first flexible hooked end 374 a of the first suturesnare 370 a is also no longer defected and transitions to an extended,relaxed state.

Referring now to FIG. 29C, after the first actuator 367 a is advancedtoward the distal end 354 of the elongated guide region 355 [655], thefirst actuator 367 a is partially retracted toward the proximal end 352of suture guide system 300 c [656]. When the first actuator 367 a ispartially retracted, the first cannula shaft 368 a is at least partiallywithdrawn from the first portion of biological tissue 60 a and thesuture 102 is engaged to and restrained by the first portion ofbiological tissue 60 a. The first suture end 102 a is also positionedwithin the first suture capture member 372 a of the first suture snare370 a.

Referring now to FIG. 31A, after the first actuator 367 a is partiallyretracted [656], the first actuator 367 a is then fully retracted [657],whereby the first actuator 367 a retracts the first suture snare 370 aand, hence, first suture end 102 a engaged thereto into the elongatedguide region 355 of the suture guide housing 350.

Referring now to FIG. 31B, after the first actuator 367 a is fullyretracted [657], the suture guide system 300 c is rotated, preferably,rotated approximately 180°, whereby a contralateral second portion ofbiological tissue 60 b is engaged by the tissue positioning region 400 cof the suture guide sub-system 300 a [658].

After the suture guide system 300 c is rotated [658], the secondactuator 367 b is advanced along the second guide slot 351 b toward thedistal end 354 of the elongated guide region 355 of suture guide system300 c [659]. According to the invention, when the second actuator 367 bis advanced, the second cannula shaft 368 b is similarly inserted intoand through the second portion of biological tissue 60 b engaged to thetissue positioning region 400 c. The second flexible hooked end 374 b ofthe second suture snare 370 b is also no longer defected and similarlytransitions to an extended, relaxed state.

The second actuator 367 b is then similarly partially retracted towardthe proximal end 352 of the elongated guide region 355 of suture guidesystem 300 c [660], whereby the second cannula shaft 368 b is similarlypartially withdrawn from the second portion of biological tissue 60 b.When the second actuator 367 b is partially retracted, the secondcannula shaft 368 b is similarly withdrawn from the second portion ofbiological tissue 60 b and the suture 102 is also engaged to andrestrained by the second portion of biological tissue 60 b. The secondsuture end 102 b is also positioned within the second suture capturemember 372 b of the second suture snare 370 b.

After the second actuator 367 b is partially retracted [660], the secondactuator 367 b is then fully retracted [661], whereby the secondactuator 367 b similarly retracts the second suture snare 370 b and,hence, second suture end 102 b engaged thereto into the elongated guideregion 355 of the suture guide housing 350.

After the second actuator 367 b is fully retracted [661], the sutureguide system 300 c is withdrawn from the biological tissue structure,e.g., abdominal wall 12, with the first and second suture ends 102 a,102 b ensnared by the first and second suture capture members 372 a, 372b, respectively [662].

After the suture guide system 300 c is withdrawn from the biologicaltissue structure [662], the first and second suture ends 102 a, 102 bare released from the first and second suture capture members 372 a, 372b are tied together, whereby the opening in the tissue structure isclosed, more preferably, ligated, fixated and closed [663].

In some envisioned embodiments of the invention, the suture guide system300 c further comprises a suture loading component that is adapted toload a suture into the cannula shafts 368 a, 368 b. In the notedembodiments, the suture 102 could run outside the housing 350 instead ofwithin the housing 350.

According to the invention, a further alternative suture guide systemthat can be employed to close biological tissue is disclosed inApplicant's U.S. Pat. No. 9,393,011, which is expressly incorporatedherein in its entirety.

As will readily be appreciated by one having ordinary skill in the art,the present invention provides numerous advantages compared to prior artmethods and systems for accessing biological tissue (and structures) andclosing openings in biological tissue. Among the advantages are thefollowing:

-   -   The provision of tissue access and closure systems that can be        readily employed to facilitate various laparoscopic surgical        procedures in a simple and economical manner.    -   The provision of tissue access and closure systems that can be        readily employed to access internal structures; particularly,        intra-abdominal structures in a minimally invasive manner.    -   The provision of tissue access and closure systems that can be        readily employed to effectively approximate, ligate, fixate and        close biological tissue; particularly, laparoscopic ports or        incisions in biological tissue.

Without departing from the spirit and scope of this invention, one ofordinary skill can make various changes and modifications to theinvention to adapt it to various usages and conditions. As such, thesechanges and modifications are properly, equitably, and intended to be,within the full range of equivalence of the following claims.

What is claimed is:
 1. A method for closing an opening in biologicaltissue, comprising the steps of: providing a tissue closure systemcomprising a suture guide sub-system and suture passer sub-system, saidsuture guide sub-system comprising an elongated first housing comprisinga first proximal end, a distal region and an open internal regiondisposed in said distal region, said distal region being configured totransition into and through a tissue structure, said first housingfurther comprising a first suture passer lumen that is sized andconfigured to receive said suture passer sub-system therein, said firsthousing further comprising an open tissue positioning region proximatesaid distal region of said first housing, said open tissue positioningregion comprising second proximal and distal ends, said first suturepasser lumen extending from said proximal end of said first housing tosaid proximal end of said open tissue positioning region, said firsthousing further comprising a second suture passer lumen that extendsfrom said distal end of said open tissue positioning region to saiddistal region of said first housing, said second suture passer lumencomprising a longitudinal axis, said first and second suture passerlumens being in an aligned relationship, wherein said suture passersub-system is capable of transitioning unobstructably from said firstsuture passer lumen into and through said open tissue positioning regionand into and through said second suture passer lumen, said distal regionof said first housing further comprising a suture retention clip havinga flexible extended door region, said suture retention clip beingdisposed in said internal region of said distal region proximate saidopen tissue positioning region, wherein said flexible extended doorregion intersects said longitudinal axis of said second suture passerlumen, wherein said extended door region forms a suture capture doorthat obstructs passage of said suture passer sub-system through saidsecond suture passer lumen, when said suture capture door is in a closedposition, said suture capture door being further configured totransition from said closed position to an open position, wherein saidextended door region allows passage of said suture passer sub-systemthrough said second suture passer lumen, said suture capture door beingfurther configured to engage and retain a first suture that isreleasably secured to said suture passer sub-system when said suturepasser sub-system and engaged first suture are inserted into and throughsaid second suture passer lumen and through said suture capture doorand, thereafter, said suture passer sub-system is withdrawn through saidsuture capture door, whereby, when said suture passer sub-system andengaged first suture are inserted into and through first tissue disposedin said tissue positioning region, into and through said second suturepasser lumen and through said suture capture door and, thereafter, saidsuture passer sub-system is withdrawn through said suture capture door,said first suture is engaged to said first tissue and retained by saidcapture door, said suture capture door being further configured toprovide a closure force in the range of 0.1-5.0 lbs_(f) when said suturecapture door is in said closed position, said suture passer sub-systemcomprising an actuator, first suture passer cannula and first suturedeployment shaft, said actuator being coupled to said first suturedeployment shaft, said first suture passer cannula being configured toslidably receive said first suture deployment shaft therein, said firstsuture deployment shaft comprising suture deployment and capture meansfor delivering said first suture to biological tissue and capturing andreleasably securing said first suture therewith, said suture passersub-system further comprising retraction means for retracting said firstsuture deployment shaft from an extended position to a plurality ofretracted positions; inserting said first proximal end of said sutureguide sub-system first housing into and through a first tissue openingin a first biological tissue structure; positioning said open tissuepositioning region of said suture guide sub-system proximate a firsttissue region of said first biological structure proximate said firsttissue opening, wherein said first tissue region is disposed in saidopen tissue positioning region; engaging a first section of a secondsuture with said suture passer sub-system; inserting said suture passersub-system and said engaged first section of said second suture intosaid suture guide sub-system, wherein said first suture passer cannulaof said suture passer sub-system is disposed proximate said first tissueregion of said first biological structure; inserting said first suturepasser cannula of said suture passer sub-system and said engaged firstsection of said second suture into and through said first tissue regionof said first biological structure and through said suture capture doorof said suture guide sub-system; withdrawing said first suture passercannula through said capture door and out of said first tissue region ofsaid first biological structure, wherein said first section of saidsecond suture is ensnared by said suture capture door of said sutureguide sub-system and routed through said first tissue region of saidfirst biological structure; withdrawing said suture passer sub-systemout of said suture guide sub-system; rotating said suture guidesub-system circumferentially, wherein a contralateral second tissueregion of said first biological structure proximate said first tissueopening is disposed in said open tissue positioning region of saidsuture guide sub-system; engaging a second section of said second suturewith said distal end of said suture passer sub-system; inserting saidsuture passer sub-system and said engaged second section of said secondsuture into and through said second tissue region of said firstbiological structure and through said suture capture door of said sutureguide sub-system; withdrawing said first suture passer cannula throughsaid capture door and out of said second tissue region of said firstbiological structure, wherein said second section of said second sutureis ensnared by said suture capture door of said suture guide sub-systemand routed through said second tissue region of said first biologicalstructure; withdrawing said suture passer sub-system out of said sutureguide sub-system; withdrawing said suture guide sub-system from saidfirst biological structure; releasing said first and second sections ofsaid second suture ensnared by said suture capture door; and drawingsaid first and second sections of said second suture together, whereinsaid first and second tissue regions of said first biological structureare drawn together and, thereby, said first tissue opening in said firstbiological tissue structure is closed.